Haematologica HAEMATOL/2019/231076 Version 3

Haematologica HAEMATOL/2019/231076 Version 3 DA-EPOCH-R combined with high-dose methotrexate in patients with newly diagnosed stage II-IV CD5-positive diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 study

Kana Miyazaki, Naoko Asano, Tomomi Yamada, Kohta Miyawaki, Rika Sakai, Tadahiko Igarashi, Momoko Nishikori, Kinya Ohata, Kazutaka Sunami, Isao Yoshida, Go Yamamoto, Naoki Takahashi, Masataka Okamoto, Hiroki Yano, Yuki Nishimura, Satoshi Tamaru, Masakatsu Nishikawa, Koji Izutsu, Tomohiro Kinoshita, Junji Suzumiya, Koichi Ohshima, Koji Kato, Naoyuki Katayama, Motoko Yamaguchi, and CD5+ DLBCL Treatment Study Group Collaborative Groups: CD5+ DLBCL Treatment Study Group) Haematologica HAEMATOL/2019/231076 Version 3

Disclosures: Disclosures KM received honoraria from Chugai Pharma, Kyowa Hakko Kirin, and Celgene; KM, NK, and MY received research funding from Sumitomo Group, Nippon Shinyaku, Chugai Pharma, Kyowa Hakko Kirin, Takeda, Astellas Pharma, Shionogi Pharmaceutical, Daiichi Sankyo, Eisai, Novartis, Pfizer, Teijin Pharma, Ono Pharmaceutical, Toyama Chemical Co, Mochida Pharmaceutical Co. Ltd., and Novo Nordisk; NA received honoraria from Takeda, Chugai Pharma, and Celgene; RS received honoraria from Chugai Pharma, Kyowa Hakko Kirin, Takeda, Ono Pharmaceutical, Eisai, Bayer, Bristol-Myers Squibb, Sumitomo Dainippon, Celgene, Mundipharma, and Janssen, research funding from Chugai Pharma, Kyowa Hakko Kirin, Takeda, Ono Pharmaceutical, Yakult Pharmaceutical, Taiho Pharmaceutical, and Eisai; TI received honoraria from Chugai Pharma and Kyowa Hakko Kirin, research funding from Zenyaku Kogyo, Sanofi, Eisai, Celltrion, and SymBio Pharmaceuticals; MN received honoraria from Eisai, Kyowa Hakko Kirin, Janssen, Ono Pharmaceutical, Chugai Pharma, MSD Japan, Pfizer, Takeda, and Sumitomo group, research funding from Eisai and Ono Pharmaceutical; KO received honoraria from Novartis, Kyowa Hakko Kirin, Shionogi Pharmaceutical, and Mochida Pharmaceutical Co. Ltd; KS received honoraria from Celgene, Ono Pharmaceutical, Takeda Pharmaceutical, and Bristol-Myers Squibb, research funding from Ono Pharmaceutical, MSD, Celgene, Abbvie, Takeda Pharmaceutical, Sanofi, Bristol-Myers Squibb, Novartis, GlaxoSmithKline, Janssen Pharmaceutical, Alexion Pharma, and Daiichi Sankyo; IY received honoraria from Kyowa Hakko Kirin, Chugai Pharma, Celgene, Taiho Pharmaceutical, and Mundipharma International, research funding from Chugai Pharma and Kyowa Hakko Kirin; GY received honoraria form Kyowa Hakko Kirin, Celgene, Takeda, Bristol-Myers Squibb, Eisai, Janssen, Chugai Pharma, and Mundipharma, research funding from Eisai and Chugai Pharma; MO received honoraria from Eisai, Janssen, Ono Pharmaceutical, Bristol-Myers Squibb, Takeda, Chugai Pharma, Kyowa Hakko Kirin, Zenyaku Kogyo, and Mundipharma, research funding from Eisai, MSD, Pfizer, Novartis, Bristol-Myers Squibb, Ono Pharmaceutical, Takeda, Astellas Pharma, Sumitomo Dainippon, Taiho Pharmaceutical, Nippon Shinyaku, Teijin Pharma, and Asahi Kasei; ST received honoraria from Eisai and Chugai Pharma; MNishikawa received honoraria from Daiichi-Sankyo, consulting or advisory role from Daiichi-Sankyo; KI received honoraria from Takeda, Chugai, Eisai, Kyowa Hakko Kirin, Janssen, Ono Pharmaceutical, Gilead Sciences, Abbvie, MSD, Novartis, Nihon Medi-Physics, Daiichi Sankyo, Otsuka, Mundhipharma, Bayer, Meiji Seika Kaisha, Shionogi Pharma, Astellas Pharma, Asahi Kasei, and Bristol-Myers Squibb, consulting or advisory role from Bayer and Celgene, research funding from Abbvie, Astellas Pharma, Amgen, Bayer, Celgene, Celltrion, Chugai Pharma, Daiichi Sankyo, Eisai, HUYA Bioscience International, Janssen, Ono Pharmaceutical, Sanofi, Solasia Pharma, SymBio Pharmaceuticals, Takeda, and Zenyaku Kogyo; TI received honoraria from Eisai, Kyowa Hakko Kirin, Zenyaku Kogyo, Chugai Pharma, Janssen, Ono Pharmaceutical, Gilead Sciences, and Takeda, research funding from Gilead Sciences, Solasia Pharma, and Chugai Pharma; JS received from honoraria from Chugai Pharma, Kyowa Hakko Kirin, Janssen, Eisai, Takeda, Celgene, and Bristol Myers Squibb, consulting or advisory role from Celgene, Jansen, Abbvie, and Zenyaku Kogyo, research funding from Kyowa Hakko Kirin, Chugai-Roche, Eisai, Takeda, Sumitomo Dainippon, Taiho Pharmaceutical, Pfizer, Celltrion, and SymBio Pharmaceuticals; KO received honoraria from Chugai Pharma and Kyowa Hakko Kirin, consulting or advisory role from SRL, research funding from Chugai Pharma and Kyowa Hakko Kirin; KK received honoraria from Chugai Pharma, Takeda, MSD, Kyowa Hakko Kirin, Janssen, Celgene, Ono Pharmaceutical, Mundipharma, and Sumitomo Group, research funding from Chugai Pharma, Takeda, Kyowa Hakko Kirin, Abbvie, Novartis, Eisai, Janssen, Celgene, and Ono Pharmaceutical; NK received honoraria from Sumitomo Group, Nippon Shinyaku, Chugai Pharma, Kyowa Hakko Kirin, Taisho Toyama Pharma, Celgene, Alexion Pharmaceuticals, Shire, Takeda, Astellas Pharma, Shionogi Pharmaceutical, Novartis, Janssen, Pfizer, Sysmex, Novo Nordisk, and Bristol-Myers Squibb; MY received honoraria from Chugai Pharma, Eisai, Takeda, Nippon Shinyaku, Kyowa Hakko Kirin, Teijin Pharma, Meiji Seika Kaisha, Celgene, and Bristol-Myers Squibb. The other authors have no relationship to disclose. Haematologica HAEMATOL/2019/231076 Version 3

Contributions: Contributions KM contributed to the conception and design of the study, provision of study materials or patients, collection and assembly of data, data analysis and interpretation, and writing of the first draft. NA, KMiyawaki, YN, KO, and KK contributed to the collection and assembly of data. TY contributed to the conception and design of the study, data analysis and interpretation. KI and JS contributed to the conception and design of the study, provision of study materials or patients, data analysis and interpretation. RS, TI, MN, KO, KS, IY, GY, NT, MO, and HY contributed to provision of study materials or patients. ST contributed to the conception and design of the study. TK contributed to the conception and design of the study, data analysis and interpretation. MNishikawa contributed to the data analysis and interpretation. NK contributed to the administrative support. MY contributed to the conception and design of the study, financial support, provision of study materials or patients, data analysis and interpretation. All authors have read and approved the final manuscript. Study investigators S Ichikawa, N Fukuhara, Y Hasegawa, Y Obara, S Chiba, S Akio, K Toyama, A Wake, A Yokoyama, T Kagoo, T Yano, Y Isobe, K Tsukasaki, M Kohri, H Takasaki, N Tomita, K Matsumoto, E Matsuura, M Tanabe, Y Masaki, M Saori, Y Kumano, N Iwaki, A Sawazaki, A Okamoto, Y Inaguma, A Asano, E Takeshige; T Kitano; T Kodaka, H Tsunemine, T Takahashi, M Makita, T Takahashi, Y Suehiro, I Choi, T Matsunaga, A Kada, N Usui, N Fujihara, T Sugio, K Sasaki, K Akashi